NCT00045448

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining flavopiridol with docetaxel in treating patients who have advanced solid tumors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 2002

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2002

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

May 30, 2013

Status Verified

December 1, 2009

Enrollment Period

3.8 years

First QC Date

September 6, 2002

Last Update Submit

May 29, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

alvocidibDRUG
docetaxelDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed advanced solid tumor that is refractory to standard therapy or for which no standard therapy exists * Measurable or evaluable disease * No symptomatic or untreated CNS metastases or primary CNS neoplasm PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * Not specified Hematopoietic * WBC at least 3,500/mm3 * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin at least 8 g/dL Hepatic * Bilirubin no greater than upper limit of normal (ULN) * SGOT/SGPT no greater than 2.5 times ULN if alkaline phosphatase no greater than ULN OR * Alkaline phosphatase no greater than 2.5 times ULN if SGOT/SGPT no greater than ULN Renal * Creatinine no greater than 1.5 mg/dL Cardiovascular * No history of cardiac arrhythmias * No congestive heart failure * No myocardial infarction within the past 6 months Other * No concurrent serious or uncontrolled infection * No diabetes not adequately controlled with medication * No peripheral neuropathy greater than grade 1 * No known allergy to docetaxel or other medications formulated in Polysorbate 80 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 2 months after study PRIOR CONCURRENT THERAPY: Biologic therapy * At least 4 weeks since prior immunotherapy Chemotherapy * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * Prior taxanes allowed * No prior flavopiridol Endocrine therapy * At least 4 weeks since prior hormonal therapy Radiotherapy * At least 4 weeks since prior radiotherapy Surgery * Not specified Other * Recovered from prior therapy * No prior enrollment in this study

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

alvocidibDocetaxel

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Gary K. Schwartz, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2002

First Posted

January 27, 2003

Study Start

April 1, 2002

Primary Completion

January 1, 2006

Study Completion

December 1, 2009

Last Updated

May 30, 2013

Record last verified: 2009-12

Locations

US(1)